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The ProSeal™ CSTD mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The ProSeal™ system also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days when used as intended.

The ProSeal™ Bag Spike with Additive Port (or "and Seal Tab" (suffixed ST model no.)) serves as an adaptor between I.V. bags and ProSeal™ CSTD components, facilitating closed system fluid transfer. The spiking port of this device is compatible with generic I.V. spikes. Additionally, the additive port (injection site) allows medication to be added to the bag using the cleared ProSeal™ Injector or Injector Plus (both Syringe Adaptors).

The injection site of the ProSeal™ Bag Spike with Additive Port (or "and Seal Tab") and all corresponding interface membranes ensure a dry connection during fluid transfer. Utilizing this component and its appropriate ProSeal™ CSTD connecting component reduces the risk of microbial ingress for up to 168 hours (7 days).

This document describes a 510(k) clearance for a medical device called "ProSeal™ Bag Spike with Additive Port." 510(k) clearances are for medical devices that are substantially equivalent to a legally marketed predicate device. This process primarily relies on demonstrating that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.

Important Note: The provided FDA 510(k) clearance letter and summary do not describe a study involving a medical device with Artificial Intelligence (AI) or machine learning (ML) capabilities. The document pertains to a physical medical device (an intravascular administration set) and its mechanical and material properties. Therefore, the questions related to AI/ML specific criteria (e.g., sample size for training set, number of experts for ground truth, MRMC studies, AI assistance) are not applicable to this specific clearance.

I will focus on the acceptance criteria and performance data provided for this physical medical device.

Acceptance Criteria and Device Performance for ProSeal™ Bag Spike with Additive Port

Since this 510(k) is for a physical medical device and not an AI/ML device, the "acceptance criteria" are based on meeting established national and international standards for medical device safety and performance, as well as demonstrating substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and the Reported Device Performance

The device performance is demonstrated by conformance to various ISO standards and validation testing. The table below summarizes the key performance areas and the general nature of the reported performance, as specific quantitative acceptance criteria or detailed results are not explicitly listed in this type of summary document, but rather conformance to the standards is stated.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact sample sizes used for each individual functional, biocompatibility, sterility, shipping, or shelf-life test. This level of detail is typically found in the full test reports, not in the 510(k) summary. For device clearances, compliance is often demonstrated by testing a statistically significant number of units to ensure performance within specifications, but the exact number isn't usually summarized here.
• Data Provenance: The document does not explicitly state the country of origin of the data. However, the submitter is Epic Medical Pte. Ltd. based in Singapore, suggesting the testing could have been conducted there or by affiliated labs. The testing refers to "bench performance verifications and validations" and "existing 510(k) cleared referred-to devices (K222929, K223674, K241988)" for leveraging data. This indicates the data is retrospective, drawing from previous tests on related and cleared devices, as well as specific new tests for the subject device. There is no indication of prospective clinical studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• Not Applicable: This criterion relates to AI/ML model validation, where human experts (e.g., radiologists) establish ground truth for image interpretation. For a physical medical device like an intravascular administration set, "ground truth" is established through engineering and biological testing against predefined performance standards and specifications, not through expert consensus on qualitative data. The "experts" would be the engineers, microbiologists, and other scientific and quality control personnel conducting the rigorous lab tests and validations.

4. Adjudication Method for the Test Set

• Not Applicable: Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or AI/ML model validation to resolve discrepancies in expert interpretations of data. For a physical device, performance is objectively measured against quantifiable technical specifications and standards (e.g., no leaks observed, flow rate within X range, microbial ingress count below threshold).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable: MRMC studies are specific to evaluating the diagnostic performance of AI-assisted systems where human readers interpret medical images or data. This device is a physical product, not an AI system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not Applicable: This criterion is for AI/ML algorithms. The performance of this device is inherently its standalone physical function.

7. The Type of Ground Truth Used

• Objective Test Results / Conformance to Standards: The "ground truth" for this device's performance is established by objective engineering measurements, chemical analyses, and biological assays that demonstrate compliance with recognized industry standards (ISO, ASTM, ANSI, USP) and the device's design specifications. Examples include:
  • Absence of leaks under specified pressure.
  • Maintaining sterility and preventing microbial ingress for 7 days.
  • Meeting pre-defined flow rates.
  • No evidence of cytotoxicity, sensitization, or pyrogenicity in biocompatibility tests.
  • Successful vapor containment.

8. The Sample Size for the Training Set

• Not Applicable: There is no "training set" in the context of a physical medical device. This term applies to machine learning models.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable: As there is no training set for a physical device, this question is not relevant.

Summary of Study that Proves the Device Meets Acceptance Criteria for this Physical Device:

The study proving the device meets acceptance criteria is a comprehensive set of bench performance verifications and validations, along with biocompatibility, sterility, shipping, and shelf-life testing.

• Purpose: To demonstrate that the ProSeal™ Bag Spike with Additive Port is safe and effective for its intended use as an intravascular administration set component, and that any differences from its predicate device (ProSeal™ Closed System Bag Access, K241988) do not raise new questions of safety or effectiveness.
• Methodology:
  • Functional Testing: The device was subjected to various mechanical and functional tests based on ISO standards (e.g., ISO 8536-4, ISO 22413, ISO 15747, ANSI AAMI CN27), including leak integrity, tensile strength, flow rate, protective cap strength, IV bag spike penetration force, and impermeability to microorganisms (demonstrated for 7 days). Vapor containment was also assessed using a NIOSH CSTD draft protocol.
  • Biocompatibility Testing: In accordance with ISO 10993-1:2018 for externally communicating devices (blood path indirect, prolonged contact), various biocompatibility tests were performed on the device's materials, leveraging data from previously cleared predicate and similar devices (K222929, K223674, K241988). These included cytotoxicity, sensitization, systemic toxicity, hemolysis, pyrogenicity, chemical characterization, and particulate matter analysis.
  • Sterility Validation: Compliance with ISO 11135:2014 for Ethylene Oxide sterilization (SAL 10⁻⁶) was demonstrated, along with pyrogen testing.
  • Shipping and Shelf-Life Validation: Simulated shipping (ASTM D 4169-16) and package integrity tests (ASTM F1980-21, ASTM F88/F88M-21, ASTM F1929-23, EN 868-5:2009) were conducted. Shelf-life of 3 years was validated using accelerated aging (ASTM 1980-21).
• Data Sourcing: Data was obtained from new tests performed on the subject device and by leveraging data from previously cleared devices (K222929, K223674, K241988) that share similar components or materials, indicating a retrospective data approach for certain aspects.
• Conclusion: The results of these tests and validations confirmed that the subject device meets all relevant performance standards and does not raise new questions of safety or effectiveness compared to the predicate device, thus demonstrating substantial equivalence.

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The ZeroClear™ Bag Access is a component of the ProSeal™ Closed System drug Transfer Device (CSTD) system. The ProSeal™ CSTD mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The ProSeal™ system also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days when used as intended.

The ZeroClear" Bag Access is a part of the ProSeal™ Closed System drug Transfer Device (CSTD), used for injecting and infusing IV fluids and drug solutions from a standard IV bag to a patient. It features a bi-directional Luer lock connector, compatible with ISO 80369-7:2021 male Luer connectors and an ISO 8536-4:2019 compliant IV bag spike, including the applicant's eZSURE™ Empty Fluid Container (cleared K223674) and eZSURE™ Empty Fluid Container with ProSeal™ Injection Site (cleared K241442).

This sterile, single-use device used with the appropriate connecting devices, ensures dry connections, minimizes exposure to contaminants and drug vapors, and reduces microbial ingress for up to 7 days. It is intended for use by health care professionals in clinical settings for handling hazardous drugs.

The Subject device will be a part of a grouping of currently, twelve (12) cleared component device offerings, to the ProSeal™ CSTD system together with Epic Medical's most recently FDA cleared CSTD devices (K241988).

The provided FDA 510(k) summary (K243976) for the ZeroClear™ Bag Access details the device and its intended use as a component of a Closed System Drug Transfer Device (CSTD). However, it does not contain the specific information requested regarding acceptance criteria and the comprehensive study details as outlined in the prompt (e.g., sample size for test set, expert qualifications, MRMC studies, standalone performance, ground truth establishment, training set size).

Instead, this document focuses on demonstrating substantial equivalence to a predicate device (ProSeal™ Closed System Bag Access, K241988), primarily through functional performance, biocompatibility, and sterility testing against recognized standards. It highlights that no animal or clinical tests were deemed applicable for this submission.

Therefore, many of the requested fields cannot be directly populated from the provided text. Based on the document, here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified in the provided text for individual tests. The document mentions "testing data" but does not give specific numbers of devices or samples tested.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether the tests were retrospective or prospective. The manufacturer is Singapore-based, but testing could occur elsewhere.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not applicable to the types of performance and safety tests conducted for this device (bench testing, biocompatibility, sterility). These tests do not involve expert interpretation or "ground truth" in the diagnostic or AI sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. Adjudication methods are typically used for studies involving human interpretation or subjective assessment, which is not the case for the physical and biological tests described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. The device is a physical medical device (component of a CSTD), not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. The ZeroClear™ Bag Access is a physical component, not an algorithm or software. Its performance is inherent to its design and materials, not a standalone algorithmic output. The performance tests mentioned (e.g., airtightness, microbial ingress) evaluate the device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For the functional, biocompatibility, and sterility tests, the "ground truth" is defined by the pass/fail criteria of the referenced international and national standards (ISO, ANSI AAMI, ASTM, USP, NIOSH). For example, a device either leaks or it doesn't, based on predefined measurable thresholds in the standards.

8. The sample size for the training set

• Not applicable. There is no mention of a "training set" as this is not a machine learning or AI device.

9. How the ground truth for the training set was established

• Not applicable. No training set is involved.

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The ProSeal™ Closed System drug Transfer Device (CSTD) mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The ProSeal™ system also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days when used as intended.

This FDA Submission is to include an authorization to legally market the ProSeal" Vented Universal Vial Adaptor to the existing ProSeal™ CSTD devices system of eleven (11) devices that were cleared for sales in the US, the most recent being the ToxiSeal™ Vial Adaptor (K241823).

The ProSeal™ Vented Universal Vial Adaptor is a component of the ProSeal™ CSTD system intended for connection with the interface membranes between any standard vials and ProSeal™ CSTD component devices for close system fluid transfer. When connected to a standard vial and engaged with a ProSeal™ Injector (Syringe Adaptor), fluid can be transferred to and from the connecting component device in a closed system. The ProSeal™ Vented Universal Vial Adaptor and its corresponding interface membranes exhibit a dry connection with the communicating surfaces in a fluid transfer. The use of this component and its appropriate ProSeal™ CSTD component device reduces the risk of microbial ingress for up to 168 hours (or 7 days). when used as intended.

The closed transfer of liquid that takes place with the use of the ProSeal™ CSTD system as follows:

• A double membrane septum design utilizing self-sealing elastomeric membranes tightly fits . together when the system components engage. A cannula within the ProSeal™ Injector housing perforates the double membrane for the transfer of liquid. When the cannula is retracted, the membranes seal off the transfer of environmental contaminants into the system and/or escape of drug or vapor concentrations outside the system, thereby minimizing the individual and environmental exposure to drug vapor, aerosols, and also minimizing the risk of microbial contamination.

The provided text is a 510(k) summary for the ProSeal™ Vented Universal Vial Adaptor. It outlines the device description, indications for use, comparison to a predicate device, and performance data supporting substantial equivalence. However, it does not describe acceptance criteria for an AI/ML-enabled medical device performance study, nor does it provide details on the specific study that would prove such a device meets acceptance criteria.

The document pertains to a physical medical device (a vial adaptor) and its mechanical, material, and sterility performance, not a software-based AI/ML device for which metrics like sensitivity, specificity, or AUC would be relevant. Therefore, most of the requested information (sample size for test set, data provenance, expert ground truth, MRMC study, standalone performance, training set details) is not applicable to this 510(k) submission.

The closest analogous information in this document relates to functional performance testing and biocompatibility testing for the physical device.

Here's how to interpret the available information in the context of the prompt, acknowledging the mismatch:

The document effectively describes the "acceptance criteria" and "study" for a physical medical device based on regulatory standards and comparison to a predicate, not an AI/ML device.

1. A table of acceptance criteria and the reported device performance

The document doesn't present a table of quantitative acceptance criteria in the typical AI/ML sense (e.g., target AUC, sensitivity). Instead, it states that the device was tested and demonstrated to be in conformance with recognized ISO and FDA standards, and that "Performance testing demonstrates that this difference [in air-vent size] does not raise new questions regarding safety and effectiveness." The acceptance criteria for this physical device are the successful completion and conformance to these standards and the demonstration of substantial equivalence to the predicate.

Here's a reinterpretation of their "acceptance criteria" based on the provided text, focusing on the functional performance tests listed:

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The ProSeal™ Closed System drug Transfer Device (CSTD) mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The ProSeal™ system also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days when used as intended.

The ProSeal™ CSTD is a sterile, single-use, pyrogen-free CSTD for the preparation, reconstitution, compounding, and administration of antineoplastic and hazardous drugs, intended for use in clinical settings by trained health care professionals and/or pharmacists.

The ProSeal™ Closed System Bag Access is a component of the ProSeal™ CSTD system which is intended for connection to a standard I.V. bag and appropriate ProSeal™ CSTD component devices for the injection and infusion of I.V. infusion fluids. It is an adaptor between IV bags and ProSeal™ CSTD components for closed system fluid transfer into and out of the I.V. bag. The Subject bag access is compatible with the ProSeal™ Injector or the ProSeal™ Injector Plus (cleared K240171) and other ProSeal™ component devices, e.g. ProSeal™ Closed System Administration Set (for infusion from the I.V. bag). The ProSeal™ Closed System Bag Access and all its corresponding interface membranes exhibit a dry connection with the communicating surfaces in a fluid transfer. The use of this component device and its appropriate ProSeal CSTD connecting component device reduces the risk of microbial ingress for up to 168 hours or 7 days, when used as intended.

The closed transfer of liquid that takes place with the use of the ProSeal™ CSTD system as follows:

• A double membrane septum design utilizing self-sealing elastomeric membranes tightly fits . together when the system components engage. A cannula within the ProSeal™ Injector Plus housing perforates the double membranes for the transfer of liquid. When the cannula is retracted, the membranes seal off the transfer of environmental contaminants into the system and/or escape of drug or vapor concentrations outside the system, thereby minimizing the individual and environmental exposure to drug vapor, aerosols, and spills, and also minimizing the risk of microbial contamination, when used as intended.

Based on the provided FDA 510(k) summary for the ProSeal™ Closed System Bag Access (K241988), here's a breakdown of the acceptance criteria and the study that proves the device meets them:

Disclaimer: This document is a 510(k) summary, which provides an overview of the substantial equivalence determination. It does not contain the full details of all the studies performed. Therefore, specific quantitative performance metrics beyond what is explicitly stated for acceptance and observed results are not available in this summary.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes functional performance, biocompatibility, sterility, shipping, and shelf-life testing. While specific quantitative acceptance criteria are not explicitly listed in a single table with corresponding numerical results, the document states conformance to various ISO and FDA recognized standards. The "Comment/Discussion" column in the comparison table indicates "Same" or "Similar" for many characteristics, implying that the acceptance criteria are met by demonstrating equivalence to the predicate device and adherence to standards.

For functional performance, the document lists the following tests and their corresponding standards, implying that meeting these standards constitutes the acceptance criteria. The performance data "supporting substantial equivalence" suggests that the device met these criteria.

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each of the functional performance, biocompatibility, or sterility tests. It refers to various ISO and ASTM standards, which typically prescribe minimum sample sizes for such tests.

• Data Provenance: The document states "Bench performance verifications and validations referred-to and performed" and "testing data on devices cleared under K222929." This indicates that the testing was primarily benchtop testing (laboratory-based) and retrospective, leveraging data from previously cleared devices within the ProSeal™ CSTD system (specifically K222929). There is no mention of data provenance by country of origin or specific patient data since the studies are physical/chemical rather than clinical.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This section is Not Applicable to this 510(k) submission. The device is a physical medical device (intravascular administration set component), not an AI/ML diagnostic or image analysis device that requires expert human interpretation to establish ground truth from medical images or clinical data. Its performance is evaluated through physical, mechanical, and biological testing against established standards.

4. Adjudication Method for the Test Set

This section is Not Applicable. Adjudication methods (like 2+1, 3+1 consensus) are typically used in clinical studies involving human interpretation or subjective assessments, especially for AI/ML devices where ground truth might be derived from multiple expert opinions. For a physical device undergoing performance and safety testing against objective engineering and biological standards, such adjudication is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of how much Human Readers Improve with AI vs. without AI Assistance

This section is Not Applicable. An MRMC study is relevant for diagnostic or AI-assisted diagnostic devices that evaluate human reader performance. The ProSeal™ Closed System Bag Access is a hardware component for drug transfer and does not involve human readers interpreting medical cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This section is Not Applicable. This concept applies to AI/ML software. The ProSeal™ Closed System Bag Access is a physical device component.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by conformance to internationally recognized performance standards (e.g., ISO, ASTM, USP, ANSI/AAMI) for medical devices, specifically for intravascular administration sets and closed system transfer devices. This includes:

• Engineering/Physical Standards: Defining acceptable ranges for leak integrity, tensile strength, penetration force, package integrity, etc.
• Biological Standards: Defining acceptable levels for biocompatibility (cytotoxicity, sensitization, systemic toxicity, hemolysis, pyrogenicity) and sterility.
• Functional Claim Validation: Demonstration of preventing microbial ingress and vapor containment as defined by specific test protocols (e.g., microbial ingress test, vapor containment test).

8. The Sample Size for the Training Set

This section is Not Applicable. The product is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the machine learning sense. The design and manufacturing processes are validated through engineering principles and compliance with quality systems (e.g., 21 CFR Part 820).

9. How the Ground Truth for the Training Set Was Established

This section is Not Applicable for the same reason as point 8.

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The ToxiSeal™ Vial Adaptor mechanically prohibits environments from entering the system and the escape of drug or vapor concentrations from the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The device also prevents the introduction of microbial contaminations into the drug or fluid path for up to 168 hours (or 7 days) when used as intended.

The ToxiSeal™ Vial Adaptor devices are single-use, sterile, non-pyrogenic CSTD drug vial adaptors that are fitted to the drug vials and are sealed against the closures of the vials. They are used as sterile interfaces between the drug vials and the ProSeal™ Injector or the ProSeal™ Injector Plus (both are syringe adaptors) for the injection of diluents into the drug vials and/or withdrawal of liquids from the vials. Changes proposed in this Special 510(k) Submission are as follow: Removed external balloon and added activated carbon filter.

The provided document is a 510(k) summary for the ToxiSeal™ Vial Adaptor (K241823). It describes the device, its intended use, a comparison to a predicate device, and performance data supporting its substantial equivalence. However, the document does not contain information about an AI/software device or a comparative effectiveness study involving human readers with and without AI assistance.

Therefore, I cannot provide information for points 5, 8, and 9 of your request as they are not present in the document.

Based on the available information regarding the medical device itself (ToxiSeal™ Vial Adaptor), here's the information related to acceptance criteria and the studies conducted:

The ToxiSeal™ Vial Adaptor is a physical medical device, not an AI/software product. Therefore, the "acceptance criteria" and "study that proves the device meets acceptance criteria" are related to its functional performance, biocompatibility, and sterility, rather than AI performance metrics.

Acceptance Criteria and Device Performance (for a physical device)

The document outlines the various tests performed to demonstrate the device's conformance to recognized standards. The "acceptance criteria" are implied by the conformance to these standards and the findings that the device "met the acceptance criteria therein" or "did not raise any new or different questions of safety or effectiveness."

Here's a table summarizing the acceptance criteria (standards/tests) and the reported device performance.

Now addressing the specific points of your request based on the provided document:

1. A table of acceptance criteria and the reported device performance

   • See the table above. Note that for a physical medical device, "acceptance criteria" are typically defined by conformance to established performance standards and successful completion of specified tests.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

   • Sample Sizes: The document does not specify the exact sample sizes used for each performance test (e.g., number of devices tested for leak integrity, biocompatibility, etc.). It mentions that tests were "performed on the Subject devices," "on devices under K241476," or "on device under K222929," implying samples were used from these device types.
   • Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given it's a 510(k) submission to the FDA, the data would typically be generated by the manufacturer or contract labs following international and US standards. The studies, being part of device verification and validation prior to market clearance, are generally prospective in nature for the tests conducted on the subject device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

   • This question is not applicable to this type of medical device submission. Ground truth established by experts (like radiologists for imaging AI) is relevant for diagnostic accuracy studies of software/AI. For a physical device like a vial adaptor, the "ground truth" is based on objective measurements against established engineering and biological standards. There are no human "experts" establishing a diagnostic ground truth here.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

   • This question is not applicable as there is no diagnostic test set or human interpretation being adjudicated. The tests are quantitative and involve laboratory measurements.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • Not applicable. This document describes a physical medical device, not an AI software. No MRMC study was conducted or is relevant for this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not applicable. This is not an algorithm/AI device. The device's performance is standalone in the sense that its mechanical and biological properties are tested independently.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • The "ground truth" for this medical device is the objective measurement of physical properties, chemical properties, and biological safety against predefined engineering, material, and biocompatibility standards. Examples include:
     • Meeting specific leakage rates.
     • Absence of fragmentation.
     • Demonstrating specified penetration force.
     • Absence of microbial ingress.
     • Absence of cytotoxicity, sensitization, systemic toxicity, pyrogenicity, and meeting particulate matter limits.
     • Maintaining sterility over shelf-life.
   • It's based on quantitative laboratory testing results compared to acceptance criteria defined by recognized standards (ISO, ASTM, USP, NIOSH).

8. The sample size for the training set

   • Not applicable. This is not an AI/machine learning device; there is no "training set."

9. How the ground truth for the training set was established

   • Not applicable. As there is no training set for an AI model, this question does not apply.

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The Empty Fluid Container is used to hold an admixture of compatible fluids for intravenous administration to a patient. Medication transfer in and out of the container is done using aseptic technique.

The eZSURE™ Empty Fluid Container (EFC) devices are empty single-use, sterile, nonpyrogenic flexible IV container devices/ bags. These are discarded after use. The Subject EFC is made of non-PVC materials. The Nexcel Film for IV bag of the Subject EFC device is composed of a flexible plastic film bag and the device is provided in a two-port configuration with closures. A closed system inlet-/ entry-/ additive- port is used for filling one or more compatible fluid(s) into the bag by a transfer set/ syringe without needle with the ProSeal™ Injector or ProSeal™ Injector Plus (cleared K240171) attached, and another port, the spiking/ administration port, is used for accessing the infusate in the bag with a standard bag spike in an IV therapy administration from the EFC. The transfer device with a male Luer lock attached with the ProSeal™ Injector (or ProSeal™ Injector Plus) is used to connect to the filling-/ additive- port for filling. The additive port incorporates a ProSeal™ Injection Site (cleared K240433) as its integrated subcomponent; hence no other injection needle/ cannula is needed. The transfer device is removed at the end of the preparation step, and the self-sealing additive-/ injection-/ filling- port secures the admixture contents until their administration.

The provided text describes the 510(k) summary for the eZSURE™ Empty Fluid Container with ProSeal™ Injection Site. It details the device's modification from a predicate device, its indications for use, and a comparison of technological characteristics. The document primarily focuses on verifying the safety and effectiveness of the modified device by leveraging testing performed on existing cleared devices and conducting additional benchtop performance verifications.

However, the provided text does not contain information about a study proving the device meets acceptance criteria in the context of diagnostic accuracy, which is what the requested questions (2, 3, 4, 5, 6, 7, 8, 9) are geared towards. These questions are typically relevant for AI/ML-based diagnostic devices where performance is measured against a ground truth and involves human experts. This device, being an "Empty Fluid Container with ProSeal™ Injection Site," is a physical medical device for fluid administration, not a diagnostic or AI-driven system.

Therefore, many of the requested fields cannot be answered from the provided input as they are not applicable to this type of device.

Here's what can be extracted and inferred based on the nature of the device:

1. A table of acceptance criteria and the reported device performance:

The acceptance criteria are primarily based on conformance to recognized international and FDA standards, and successful performance in benchtop verification tests. The "reported device performance" is that it conforms to these standards and passed the tests.

For the remaining questions, they are not applicable or the information is not provided in the text for this medical device:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Not provided. The document describes benchtop performance verifications, which typically involve a specified number of units tested according to the method, rather than "test sets" of patient data. Details on the exact number of units tested for each benchmark are not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This device does not involve expert interpretation or ground truth establishment in the diagnostic sense. Performance is assessed against engineering and biological standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. This relates to diagnostic interpretation, not physical device performance.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is for AI-assisted diagnostic devices.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is for AI-driven algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this medical device is adherence to established international and FDA recognized standards for medical devices (e.g., ISO, ASTM, USP standards for material safety, sterility, physical integrity, leakage, etc.). For biocompatibility, the ground truth is the biological response meeting safety thresholds according to ISO 10993.

8. The sample size for the training set

• Not applicable. This is for AI/ML models; this device is a physical product.

9. How the ground truth for the training set was established

• Not applicable. This is for AI/ML models.

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The ProSeal™ Closed System drug Transfer Device (CSTD) mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The ProSeal™ system also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days, when used as intended.

The ProSeal™ Injection Site Extended Male Luer Lock (ProSeal™ Injection Site) is a new component device for the ProSeal™ Closed System (drug) Transfer Device (CSTD) system. It is intended for connection with interface membranes between any standard female Luer lock port and ProSeal™ CSTD component devices for closed system fluid transfer. It is a variant of the cleared ProSeal™ Connector, a component of the ProSeal™ CSTD system. When connected to a female Luer lock port and engaged with a ProSeal™ Injector or a ProSeal™ Injector Plus (K240171) (Syringe Adaptor), fluid can be transferred to the connecting device in a closed system. The ProSeal™ Injection Site and its corresponding interface membranes exhibit a dry connection with the communicating surfaces in a fluid transfer. The use of this component and its appropriate ProSeal™ CSTD component device reduces the risk of microbial ingress for up to 168 hours of 7 days, when use as intended. The closed transfer of liquid utilizes a double membrane septum design with self-sealing elastomeric membranes. Modifications from the existing ProSeal™ Connector include a geometric design change and a material change of the membrane from TPE to polyisoprene.

This is a 510(k) premarket notification for a medical device, specifically the ProSeal™ Injection Site Extended Male Luer Lock (model 422140). The document asserts "substantial equivalence" of this device to a previously cleared predicate device, the ProSeal™ CSTD's Connector (K240171).

The provided text does not contain any information about a study proving the device meets acceptance criteria related to AI/algorithm performance (e.g., sensitivity, specificity, or human reader improvement with AI assistance). This document concerns a physical medical device (an intravascular administration set component) and its functional, biocompatibility, and sterility performance, comparing it to an already cleared similar device.

Therefore, the requested information regarding acceptance criteria and a study proving an AI/algorithm device meets these criteria cannot be extracted from this document. The concepts of "test set," "training set," "ground truth experts," "adjudication," "MRMC study," and "standalone algorithm performance" are not applicable to the type of device and submission described in this FDA clearance letter.

The document discusses "functional performance acceptance criteria" for the physical device, which are met through conformance to various ISO and FDA recognized standards.

Here's an interpretation of the document's content relevant to "acceptance criteria" for this physical device:

Acceptance Criteria and Reported Device Performance (Non-AI Device)

Regarding the other requested points (not applicable to this document's content):

2. Sample size used for the test set and data provenance: Not applicable. This document refers to bench testing of a physical device, not a performance study on an ML model's test set.
3. Number of experts used to establish the ground truth for the test set and qualifications: Not applicable. Ground truth for an AI model is not relevant to the evaluation of this physical medical device.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI/ML model for this device. For the physical device, "ground truth" would be the objective measurement against established ISO/FDA standards.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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